Legal

Trouble Ahead for Alexion's Biosimilar Defense Strategy?

November 23rd 2019

By Kelly Davio

Roche’s Japan-based subsidiary, Chugai Pharmaceutical, has filed a new patent infringement suit against Alexion in the District Court of Delaware.

FDA Says a "Broken Marketplace" to Blame for Drug Shortages

October 30th 2019

By Allison Inserro

Given how markets operate, pharmaceutical companies need financial incentives in order to keep providing a reliable stream of high-quality products that otherwise, due to low prices and other factors, might fall into shortage, according to an FDA report about the drug shortages problem released this week.

Bipartisan Patent Transparency Bill Introduced in House of Representatives

October 28th 2019

By Allison Inserro

A bipartisan bill to require patent transparency in an effort to bring down the cost of prescription drugs has been introduced in the House of Representatives; the bill is a piece of companion legislation to one introduced in the Senate in March.

Humana Alleges Price Fixing in Lawsuit Against Generic Drug Makers

October 21st 2019

By Kelly Davio

On Friday, Humana filed a lawsuit in the Eastern District of Pennsylvania, alleging that 37 defendants engaged in a “far-reaching conspiracy” to “blatantly fix the price” of generic drugs.

AbbVie Says Antitrust Case Over Humira Could "Chill Medical and Therapeutic Innovation"

October 16th 2019

By Kelly Davio

In a memorandum in support of its motion to dismiss the suit, AbbVie says that the complaint seeks to “upend the well-settled balance between the patent and antitrust laws,” that the complaint would end international early-entry patent settlements that do not have the same global market entry date, and that it would “chill medical and therapeutic innovation.”

Nevada Tells 21 Diabetes Drug Makers They Owe $17.4 Million for Violating Transparency Law

October 7th 2019

By The Center for Biosimilars Staff

The state’s Department of Health and Human Services this week sent letters to firms that did not provide required information about production costs, marketing and advertising costs, patient assistance programs, wholesale acquisition costs, and historical increases, among other information.

Bipartisan ACCESS Act Would Eliminate Patient Co-payment for Biosimilars in Part B

October 2nd 2019

By Kelly Davio

A newly introduced item of legislation proposes to eliminate co-payments for patients when they receive a biosimilar rather than an originator biologic in Medicare Part B.

Can Congress Speed Biosimilars to Market by Limiting Patent Litigations?

September 30th 2019

Using data compiled for BiologicsHQ.com, we analyzed 2 bills that propose changes to patent litigation by limiting the number of patents a reference product sponsor can assert in a patent litigation to see how many biosimilar cases they would have impacted so far and whether they would really help bring biosimilars to market sooner.

Pfizer Confirms It Plans to Launch Bevacizumab Biosimilar on December 31

September 30th 2019

By Kelly Davio

In an email to The Center for Biosimilars®, a Pfizer representative said that, after having agreed to the terms of a settlement with Genentech and Roche that provides the biosimilar developer with global licenses for its product, Pfizer plans to launch its biosimilar bevacizumab, Zirabev, in the US market on December 31, 2019.

Arrow Declarations Are an Emerging Feature in the Biosimilar Patent Landscape

September 27th 2019

By Kelly Davio

In the US context, legal issues surrounding patents are often cited as one of the main hurdles to biosimilars. Despite the fact that patents on innovator drugs are often fewer in Europe, the patent landscape in the European Union remains complex and continues to evolve. During the SMi 10th Annual Biosimilars Conference, Gregory Bacon, DPhil, GDipIPLaw, partner at Bristows LLP, gave attendees a closer look at one emerging feature of the EU patent landscape that is of particular concern to biosimilar developers: the Arrow declaration.